Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 0.05%
Ocular Inflammation & Pain
Initate 24 hours postop: Instill 1 gtt in conjunctival sac of affected eye(s) q6hr for 2 weeks, then q12hr for1 week, then taper and discontinue
Uveitis
Indicated for treatment of endogenous anterior uveiti
Instill 1 ftt into conjunctival sac to affected eye(s) q6hr for 14 days and then taper dose downward as clinically indicated
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Increased IOP
Anterior chamber inflammation
Corneal edema
Conjunctival edema
Blepharitis
Cataract
Optic nerve damage
Abnormal healing (after surgery)
Local irritation
Punctate keratitis
Hyperemia
Punctate keratitis
Decreased visual acuity
Eye pain
Photophobia
Postmarketing Reports
Elevated intraocular pressure
Posterior subcapsular cataract formation
Secondary ocular infection
Perforation of the globe
Warnings
Contraindications
Most active viral diseases of cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures
Cautions
Not for intraocular administration
Prolonged use of corticosteroids may result in glaucoma with damage to optic nerve, defects in visual acuity and fields of vision; steroids should be used with caution in presence of glaucoma; monitor intraocular pressure if product used for ≥10 days
May increase risk of posterior subcapsular cataract formation
The use of steroids after cataract surgery may delay healing and increase incidence of bleb formation; perforations, associated with thinning of cornea or sclera, may occur; initial prescription and renewal of medication order beyond 28 days should be made by a physician only after examination of patient with aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining
Employment of corticosteroid medication in treatment of patients with history of herpes simplex requires great caution; use of ocular steroids may prolong course and may exacerbate severity of many viral infections of the eye (including herpes simplex)
Prolonged use of corticosteroids may suppress host response and thus increase hazard of secondary ocular infections; in acute purulent conditions, steroids may mask infection or enhance existing infection; if signs and symptoms fail to improve after 2 days, patient should be re-evaluated
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where steroid has been used or is in use; fungal culture should be taken when appropriate
The drug should not be instilled while wearing contact lenses; remove contact lenses prior to instillation; the preservative may be absorbed by soft contact lenses; lenses may be reinserted after 10 minutes following administration of this drug
Pregnancy & Lactation
Pregnancy
Shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day; the no- observed-effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females
Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic; at 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females
It is difficult to extrapolate these doses of difluprednate to maximum daily human dose of this drug, since this drug is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies; however, since use of this drug during human pregnancy has not been evaluated and cannot rule out the possibility of harm, this drug should be used during pregnancy only if potential benefit justifies potential risk to embryo or fetus
Lactation
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Exercise caution when therapy administered to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antiinflammatory corticosteroid; inhibits inflammatory response including capillary dilation, edema, leukocyte migration, and scar formation
Absorption
Absorption: Negligible absorption
Metabolism: Undergoes deacetylation to active metabolite
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Durezol ophthalmic (eye) - | 0.05 % drops | ![]() |
Copyright © 2010 First DataBank, Inc.
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